U.S. District Judge Amy Berman Jackson in Washington
yesterday overturned an FDA decision that kept Watson from
sharing the exclusive period granted companies that are first to
file for the right to market generic versions of branded drugs.
Actos is the world’s top-selling diabetes medicine.

Jackson ordered the FDA to immediately allow Watson to
participate in what remains of the 180-day exclusivity period
awarded previously to competitors Mylan Inc. and Ranbaxy
Laboratories Ltd. Only the order was made public. Jackson sealed
her opinion, pending arguments by the parties, because trade
secrets were disclosed in the litigation.

Watson sued the FDA in August, claiming the agency’s
decision to bar it from participating in the exclusivity period
was “arbitrary, capricious and contrary to law,” according to
the company’s complaint.

Sandy Walsh, a spokeswoman for the FDA, said she was unable
to comment immediately on the ruling.

Actos is the trade name of pioglitazone hydrochloride, the
diabetes medicine marketed by Osaka, Japan-based Takeda. Actos
had sales of about $3.4 billion in 2009, Watson said in court
papers, citing market researcher IMS Health.

Watson and its two competitors reached a settlement with
Takeda in 2010 after “protracted” patent litigation, which
allowed it to start selling the generic version of the drug on
Aug. 17, 2012, according to court documents. Based on the
settlement and communications with the FDA, the Parsippany, New
Jersey-based company was preparing to sell its pioglitazone
product and promised delivery to customers, according to the
complaint.

In August, the FDA “informed Watson it had reached a
decision to award another filer or filers a period of 180-day
exclusivity,” according to Watson’s complaint. “FDA has failed
to provide any explanation or basis for its determination,” the
company claimed.

Generic-drug companies are given six months of limited
competition under the Hatch-Waxman Act, passed in 1984 to
promote quick applications that will lower the price of drugs.
The concession gives drugmakers the ability to keep prices close
to the branded level and set up distribution networks before
others enter the market. When more than one company files at the
same time, they may be granted shared exclusivity by the FDA.

The case is Watson Laboratories Inc. v. Sebelius, 1:12-cv-
01344-ABJ, U.S. District Court, District of Columbia
(Washington).

Volcano Pursues Countersuit Against St. Jude in Patent Trial

Volcano Corp., a maker of cardiac catheter devices, asked a
jury to find that its patents were infringed by rival St. Jude
Medical Inc. (STJ) three days after defeating patent claims brought by
St. Jude.

St. Jude, based in St. Paul, Minnesota, initially sued San
Diego-based Volcano in federal court in Wilmington, Delaware, in
July 2010, alleging violation of patents for wires threaded
through blood vessels for diagnosis of heart disease. Volcano
countersued, pursuing claims over three patents against St.
Jude.

After a week-long trial, a jury decided Oct. 19 that
Volcano didn’t infringe two St. Jude patents and that two others
were invalid, according to a Volcano filing. Trial on Volcano’s
claims began yesterday with a new jury.

Volcano “invented the technology” for the wires and
sensors, its lawyer, Frank E. Scherkenbach, told jurors in his
opening statement. He said St. Jude’s products “perform
substantially the same way.”

St. Jude is “a true innovator,” countered lawyer John
Allcock, representing St. Jude, in his initial presentation to
the jury. “They came up with a revolution” in heart treatment.

U.S. District Judge Richard G. Andrews ordered two trials,
the latest scheduled to last through the week.

St. Jude, with about $5 billion in revenue last year, said
last week it may get a regulatory warning letter about a
defibrillator factory in California.

Volcano, with $343.5 million in 2011 revenue, said Oct. 4
it had received clearance to sell a new Visions ultrasound
catheter in the U.S. and Europe to help diagnose large-vessel
disease.

The original case is St. Jude Medical v. Volcano Corp. (VOLC), 10-
cv-631, U.S. District Court, District of Delaware (Wilmington).

For more patent news, click here.

Trademark

Nordstrom Sues NoMoreRack for Infringing ‘Rack’ Trademarks

Nordstrom Inc., the Seattle-based fashion retailer, sued
the operator of a Canadian flash sale site for trademark
infringement.

The company objects to the domain name and brands used by
NoMoreRack Retail Group Inc. of Vancouver, British Columbia.

According to the complaint filed Oct. 19 in federal court
in Seattle, the Canadian company is trying to piggyback on the
fame associated with the Nordstrom Rack discount stores.
Nordstrom says it now has more than 100 off-price Rack stores in
the U.S. and that this unit of the company has become a $2
million-a-year enterprise.

In its pleadings, Nordstrom said that from 15 percent to 20
percent of the goods sold at its Rack units were originally
offered in Nordstrom stores, with the remainder being special-
purchase merchandise Nordstrom acquired from manufacturers
especially for its off-prince unit.

NoMoreRack began offering so-called flash sales in about
2010, Nordstrom said, explaining these are sites where
particular sets of merchandise are sold for a short period of
time for deeply discounted prices.

The Canadian company is accused of choosing its name “with
the intent of trading off the goodwill” associated with
Nordstrom’s Rack marks. Nordstrom said it’s harmed by this
action and the public is confused.

The two companies have, to no avail, tried to resolve the
conflict, Nordstrom said. The Seattle company asked the court
for orders barring what it says is infringement of its marks,
and awards of money damages, attorney fees and litigation costs.

NoMoreRack didn’t respond immediately to an e-mailed
request for comment.

The case is Nordstrom Inc. (JWN), v. NoMoreRack Retail Group
Inc., 2:12-cv-01853, U.S. District Court, Western District of
Washington (Seattle).

Ferrero Told Pursuing Infringement Damages May Be Waste of Money

Ferrero SpA, the Italian confectioner, has been advised to
“just move on” instead of trying to seek damages in a
Singapore trademark case involving the “Nutella” trademark,
AsiaOne.com reported.

An appellate court in Singapore said that even though the
cafe that had offered an espresso drink known as “Sarika’s
Nutello” was found to have infringed, that Ferrero might find
it expedient not to incur more costs in seeking a damages award,
according to AsiaOne.com.

The offending cafe last offered the drink more than two
years ago, according to the court, AsiaOne.com reported.

Earlier Singapore’s High Court had found infringement and
that at least 30 percent of the potential consumers would be
likely to assume some connection existed between Ferrero and the
cafe, according to AsiaOne.com.

For more trademark news, click here.

Copyright

ALRC May Have Anti-Copyright Bias, Content Industries Claim

A group appointed to review Australia’s copyright law is
accused of conflict of interest and anti-commercial bias, the
Australian reported.

A coalition of content industries claims the members of the
Australian Law Reform Commission -- academics, consumer
advocates and bureaucrats -- lack experience in and
understanding of the commercial sphere, according to the
newspaper.

They claim no one on the committee will be “directly
impacted” by any changes in the law, the newspaper reported.

Rosalind Croucher, who heads the committee, said in
response that the committee has agreed to establish set up a
group for the entertainment industry to provide input, according
to the Australian.

Universal, Pennsylvania Mother Await Case Dismissal Ruling

Universal Music Group’s motion to dismiss a case brought by
a mother over a video of her dancing toddler has been argued and
is now under submission to a federal judge in San Jose,
California.

Stephanie Lenz of Gallitzin, Pennsylvania, sued the music
company in July 2007 after Google Inc.’s YouTube video-sharing
site removed a video she posted. Universal had objected to
Lenz’s use of Prince’s song “Let’s Go Crazy” to accompany her
brief piece showing her toddler dancing, and filed a takedown
request under the Digital Millennium Copyright Act.

She claimed that copyright law’s “fair use” provision
permitted her use of the music.

In March 2012 the court ruled that Lenz -- who is being
assisted by the San Francisco-based digital-rights group
Electronic Frontier Foundation -- didn’t file the suit in bad
faith. Universal at that time had also asked for a dismissal of
the case.

According to an Oct. 16 court filing, both parties
submitted oral arguments on Universal’s request to dismiss the
case. The judge said he will issue a written ruling.

The North Carolina Utilities Commission rejected the
company’s contention that these e-mails should be protected from
disclosure because they contain company trade secrets, according
to the News Observer.

The commission said in an Oct. 19 order that there was no
evidence that anyone could benefit economically from disclosure
of the e-mails, the newspaper reported.

The order gave Duke 10 days to reveal the e-mails or go to
court and try to halt their disclosure, according to the News
Observer.